No­var­tis’ Tafin­lar (dabrafenib) and Mekin­ist (tram­e­tinib) com­bo has been ap­proved for an­oth­er in­di­ca­tion by the FDA — this time for treat­ment of low-grade glioma with a BRAF V600E mu­ta­tion in kids aged 1 year and up.

This marks the sixth ap­proval for the com­bi­na­tion. It’s al­ready ap­proved for use in mul­ti­ple BRAF V600E sol­id tu­mors, in­clud­ing melanoma, thy­roid can­cer and lung can­cer.

Liq­uid for­mu­la­tions for both drugs were al­so ap­proved by the FDA, which No­var­tis said is the first time a BRAF/MEK in­hibitor has been de­vel­oped in a for­mu­la­tion suit­able for pa­tients as young as one.

Ac­cord­ing to No­var­tis, low-grade glioma is the most com­mon pe­di­atric brain can­cer, while BRAF V600 mu­ta­tions are present in 15% to 20% of pe­di­atric low-grade glioma cas­es.

Reshe­ma Kemps-Polan­co

“This new in­di­ca­tion for Tafin­lar and Mekin­ist is a po­ten­tial new stan­dard of care treat­ment op­tion for young pa­tients with this form of brain can­cer with a BRAF V600E mu­ta­tion, in for­mu­la­tions specif­i­cal­ly de­signed for them,” Reshe­ma Kemps-Polan­co, ex­ec­u­tive VP of US on­col­o­gy at No­var­tis, said in a state­ment.

The FDA is­sued its ap­proval based on re­sults from Phase II/III tri­als that showed pa­tients on the com­bo had an im­prove­ment in over­all re­sponse rate of 47% com­pared to 11% of pa­tients on chemother­a­py.

Pro­gres­sion-free sur­vival was bet­ter for pa­tients on the com­bi­na­tion, too. Af­ter 18.9 months, me­di­an pro­gres­sion-free sur­vival for pa­tients on the com­bi­na­tion was 20.1 months com­pared to 7.4 months just on chemother­a­py (p=<0.001).

The drugs brought in $1.7 bil­lion in 2022, ac­cord­ing to No­var­tis.

In 2022, Tafin­lar and Mekin­ist broad­ened their la­bel wide­ly by adding any sol­id tu­mor in pa­tients with BRAF V600E mu­ta­tions whose can­cers are un­re­sectable or metasta­t­ic. The com­bo was ap­proved for pa­tients as young as six.

Mekin­ist first hit the mar­ket in 2013 for ad­vanced melanoma. GSK, which owned the drug at the time, then paired Mekin­ist with Tafin­lar for a 2014 ap­proval in the same in­di­ca­tion. A few months af­ter that com­bo ap­proval, GSK sold it (and most of the rest of its on­col­o­gy port­fo­lio) to No­var­tis. No­var­tis paid rough­ly $16 bil­lion, com­plet­ing the deal in March 2015.

The mRNA player Moderna is further cementing its presence on the African continent.

Moderna announced on Thursday that it has finalized an agreement with Kenya’s government to partner up and bring an mRNA manufacturing facility to the east African nation. The new facility aims to manufacture up to 500 million doses of vaccines annually. Moderna also said the new facility will have the ability to spike its production capabilities to respond to public health emergencies on the continent or globally.

Thermo Fisher Scientific is putting down more roots in the Bay Area.

The manufacturer opened the doors to a new cell therapy manufacturing facility next to the University of California-San Francisco Medical Center’s Mission Bay campus and on the university’s campus.

UCSF and Thermo Fisher have had a partnership since 2021, with the new site focusing on manufacturing cell therapeutics for certain cancers, including glioblastoma and multiple myeloma. The new site plans to use Thermo Fisher’s expertise in manufacturing services to help UCSF accelerate the development of cell therapies and eventually get them into the clinic, said Dan Herring, the general manager of cell therapy services at Thermo Fisher, in an interview with Endpoints News.

When Vigil Neuroscience filed its IPO papers in late 2021, the biotech revealed that the FDA had just cleared its Phase I trial — but with a partial clinical hold that limited dosing to under a certain level.

More than a year later, the FDA has lifted the hold.

Vigil is now free to dose VGL101, an antibody targeting TREM2, at levels higher than 20 mg/kg in its ongoing and future clinical trials in patients with adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP), an inherited condition that affects the brain and spinal cord.

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

Boehringer Ingelheim reported human pharma sales of €18.5 billion on Wednesday, led by type 2 diabetes and heart failure drug Jardiance and pulmonary fibrosis med Ofev. Jardiance sales reached €5.8 billion, growing 39% year over year, while Ofev took in €3.2 billion, notching its own 20.6% annual jump.

However, Boehringer is also looking ahead with its pipeline, estimating “In the next seven years the company expects about 20 regulatory approvals in human pharma.”

Catalent will be manufacturing a low-cost version of the opioid overdose treatment naloxone as part of a contract with Harm Reduction Therapeutics.

Catalent plans to manufacture the treatment at its facility in Morrisville, NC. No financial details on the deal were disclosed.

Harm Reduction was granted priority review status for the NDA on its spray last year. The company has been working on a naloxone product since 2017. It is anticipating approval in July of this year and a US launch in early 2024.